Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT03257163
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Epstein-Barr Virus Positive
  • Gastric Adenocarcinoma
  • Mismatch Repair Protein Deficiency
  • Stage IB Gastric Cancer AJCC v7
  • Stage II Gastric Cancer AJCC v7
  • Stage IIA Gastric Cancer AJCC v7
  • Stage IIB Gastric Cancer AJCC v7
  • Stage III Gastric Cancer AJCC v7
  • Stage IIIA Gastric Cancer AJCC v7
  • Stage IIIB Gastric Cancer AJCC v7
  • Stage IIIC Gastric Cancer AJCC v7

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Radiation Therapy — RADIATION
    Undergo radiation therapy

Study Details

This phase II trial studies how well pembrolizumab works with capecitabine and radiation therapy in treating patients with mismatch repair deficient and Epstein-Barr virus positive gastric cancer. Monoclonal antibodies, such as pembrolizumab may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, capecitabine and radiation therapy may work better at treating gastric cancer.

Key Dates

First listed
Aug 22, 2017
Start date
Sep 29, 2017
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pembrolizumab, capecitabine, radiation therapy)
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks, patients undergo surgery. Beginning up to 56 days after surgery, patients receive pembrolizumab IV over 30 minutes on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks of resting, patients continue to receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity. Beginning course 4, patients undergo radiation therapy over 15-30 minutes on days 1-5 for up to 5 weeks.

Primary Outcome Measure

Recurrence-free survival (RFS) rate [ Time Frame: 3 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30308-
RWJBarnabas Health - Robert Wood Johnson University Hospital, HamiltonHamiltonNew Jersey08690-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Montefiore Medical CenterThe BronxNew York10467-

Find similar trials in Atlanta, GA

By research site
Emory University· Atlanta, GARWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton· Hamilton, NJRutgers Cancer Institute of New Jersey· New Brunswick, NJMontefiore Medical Center· The Bronx, NY

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